After a year marked by leadership turnover, shifting policies, and now the departure of Vinay Prasad, the question facing the FDA isn’t just about who’s in charge – it’s about whether the agency can provide the predictability biopharma companies need to operate.

In an interview with BioPharma Dive, Managing Partner Michael Abrams explained that when regulatory expectations become unclear or change midstream, it adds another handicap for an industry already navigating significant challenges.

We’re talking about investments of millions if not billions of dollars, and organizations need some kind of predictability about what the rules are.

Abrams added that the FDA now has an opportunity to reset and focus on restoring stability, rebuilding confidence, and implementing change in a more measured, incremental way.

Read the full story at biopharmadive.com.